Kiromic BioPharma Moves Forward with Deltacel-01 Expansion
Kiromic BioPharma Receives Approval for Deltacel-01 Trial
Kiromic BioPharma, Inc. (OTCQB: KRBP) has announced an exciting development in their clinical research. The Safety Monitoring Committee (SMC) has unanimously approved the expansion phase of the Deltacel-01 clinical trial. This study investigates Deltacel™ (KB-GDT-01), a groundbreaking therapy using Gamma Delta T-cells (GDT) designed specifically for patients grappling with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not found success with standard treatments.
Understanding Deltacel-01 Clinical Trial
As the trial progresses into its expansion phase, Kiromic plans to enroll about nine additional participants. The commencement of screening for these new patients is anticipated soon. This phase, known as Part 2 of Deltacel-01, aims to further evaluate the effectiveness and potential of Deltacel treatment, which is crucial for addressing significant unmet needs in oncology.
What We’ve Learned from Initial Phases
The recommendation for this trial progression followed a careful analysis of safety data from the initial phases, highlighting a promising safety and tolerability profile without any dose-limiting toxicities (DLTs). This safety aspect is particularly critical in oncology, where treatment options often come with substantial side effects.
Company Insights from Kiromic’s Leadership
Pietro Bersani, the Chief Executive Officer of Kiromic BioPharma, expressed his optimism about this advancement. “We are delighted to receive unanimous SMC approval to move forward with the expansion phase of the Deltacel-01 trial,” he noted. The CEO emphasized the company’s confidence in achieving a consistent pace of patient enrollment with the activation of more clinical sites, underscoring their commitment to investigating the therapeutic impact of Deltacel.
Overview of the Deltacel Therapy
Deltacel™ (KB-GDT-01) represents an innovative approach in cancer immunotherapy. The current open-label Phase 1 trial has been meticulously designed to assess the safety and tolerability of these Gamma Delta T-cell infusions combined with low-dose radiotherapy. Each participant in the study will receive two infusions within a 10-day period alongside localized radiation treatments.
Objectives and Expectations of the Trial
The primary aim of the Deltacel-01 trial is to ensure the safety of the treatment, while secondary goals measure various outcomes including objective response rates, progression-free survival, and overall survival rates. These indicators will provide valuable insights into the efficacy of Deltacel™ against advanced NSCLC.
Deltacel: A Closer Look
Specifically designed for treating solid tumors like NSCLC, Deltacel™ is an allogeneic product, which means it’s derived from donor cells. This type of therapy leverages the natural power of Gamma Delta T-cells to attack and eliminate cancer cells efficiently. Kiromic’s formulation aims to harness the body's own immune response to combat the significant challenges posed by solid tumors.
Supporting Data for Deltacel
Preliminary data from earlier studies have suggested that when combined with low-dose radiation, Deltacel™ exhibits favorable safety and efficacy. This synergy may enhance treatment outcomes for patients who have limited options available to them.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a pioneering clinical-stage biotherapeutics company focusing on immuno-oncology. They utilize an advanced artificial intelligence target discovery engine named DIAMOND® to streamline the development of cell therapies. This innovative platform not only aims to expedite the creation of cancer treatments but also to significantly reduce the associated costs.
Frequently Asked Questions
What is Deltacel-01?
Deltacel-01 is a clinical trial evaluating the safety and effectiveness of Deltacel™ therapy for treating stage 4 metastatic non-small cell lung cancer.
What are the primary goals of the Deltacel-01 trial?
The primary goal is to assess safety, while secondary goals measure response rates, progression-free survival, and overall survival rates.
Who can participate in the Deltacel-01 trial?
The trial is open to patients diagnosed with stage 4 non-small cell lung cancer who have not responded to standard treatments.
What makes Deltacel™ unique?
Deltacel™ uses unmodified, donor-derived Gamma Delta T-cells, targeting solid tumors with a focus on enhancing the body's immune response.
How does Kiromic BioPharma innovate in cancer treatments?
Kiromic leverages their proprietary DIAMOND® AI technology to optimize the drug discovery process, making it faster and more cost-effective.
About Investors Hangout
Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/
Disclaimer: The content of this article is solely for general informational purposes only; it does not represent legal, financial, or investment advice. Investors Hangout does not offer financial advice; the author is not a licensed financial advisor. Consult a qualified advisor before making any financial or investment decisions based on this article. The author's interpretation of publicly available data shapes the opinions presented here; as a result, they should not be taken as advice to purchase, sell, or hold any securities mentioned or any other investments. The author does not guarantee the accuracy, completeness, or timeliness of any material, providing it "as is." Information and market conditions may change; past performance is not indicative of future outcomes. If any of the material offered here is inaccurate, please contact us for corrections.
Related Articles
- Bank of America Advises Caution with US Dollar's October Bounce
- Investors Urged to Take Action with DXC Technology Group
- Global Uranium Corp. Enhances Leadership with New CFO Appointment
- STEP Energy Services Limited Enhances Financial Stability with New Credit Terms
- Koi Nation's Casino Project Advances with Compliance to Laws
- Natural Grocers Celebrates New Store Opening with Exciting Events
- Avenue Therapeutics Appoints Executives with Equity Awards
- Citi Attributes Neutral Rating on Coloplast with DKK930 Target
- nLIGHT Enhances Financial Flexibility with Credit Amendment
- CMC Metals Ltd. Moves Forward with Warrant Extensions Plan
Recent Articles
- Oppenheimer Boosts Tyra Biosciences Price Target Amid Growth
- Takeda Shares Groundbreaking Findings on Narcolepsy Treatment
- Ocular Therapeutix Gains Momentum with Axpaxli Potential
- SINTX Technologies Secures $3.1 Million in Equity Offering
- Menlo Security Earns Leadership Position in GigaOm Analysis
- USANA Athletes Shine with 99 Medals at Major Competitions
- Discover the Unique Four Seasons Jet Experience Coming Soon
- Somfy North America Unveils Innovative SDN Connect Solution
- Pinpoint Predictive Joins NAMIC to Enhance Insurance Solutions
- Morgan Stanley Downgrades Antofagasta: Insights and Analysis
- Axlab Launches Advanced Robotic Technology in the US Market
- Transforming Healthcare: Meet PAULA, the AI for Prior Authorizations
- Zura Bio's Strategic Moves and Analyst Confidence Boost Shares
- Norton Transport Aims to Eliminate 2.5 Tons of Ocean Waste
- Helsinn Group Welcomes Riccardo Carbucicchio to Board
- Colibri Real Estate Unveils Unique Negotiation Certifications
- V&S Galvanizing Welcomes Rich Collins as New CEO
- Highlights from Filevine’s LEX Summit 2024: Innovations Unveiled
- LPO MSA's Breakthrough in Multi-Vendor Equipment Testing
- Edward Jones Boosts Duke Energy Outlook with Strong Buy Rating
- TRI-COR Industries Secures Major IT Services Contract
- Future of Personal Mobility Devices: Expanding Beyond Limits
- Enhancing School Safety through Innovative Technology
- Leadership Changes at Prilenia: New CFO and CLO Appointed
- ZORYVE Cream Receives Positive Results for Atopic Dermatitis
- DCN Dx Showcases miniDxR at International Diagnostics Event
- Future of Solar Panels: Insights on Market Growth and Trends
- Comcast Advertising Appoints Scott Weisenthal as Marketing Leader
- Dr. Quarraisha Abdool Karim Joins GHIT Fund Board of Directors
- Gorilla Technology Completes Share Buyback Amid Growth Strategies
- Horizon3.ai Welcomes Nicholas Warner to Board for Cybersecurity Growth
- Innovative Trends in the Growing Hispanic Market Revealed
- Humacyte's Innovative Diabetes Device Receives US Patent Approval
- ClearSale Welcomes New Leaders to Propel Growth Forward
- TRM Labs Achieves FedRAMP Moderate Authorization for Security
- Picus Security Secures $45 Million for Advanced Cybersecurity Solutions
- Corning Looks Towards Major Growth in Display Technology
- Rezolve AI Celebrates Major Investment Transforming AI Landscape
- AngioDynamics Set to Unveil Financial Insights for Q1 2025
- Apogee Minerals Advances Exploration at Pine Channel Projects
- SINTX Technologies Successfully Raises $3.11 Million in Offering
- ReposiTrak, Inc. Announces Quarterly Cash Dividend Details
- BODi and Truemed: A Game-Changer for Wellness Spending
- Mastercard Predicts Steady Growth in US Holiday Sales for 2024
- Arcutis Biotherapeutics Reports Promising Results for ZORYVE
- Fairbanks Morse Defense Strengthens Naval Capabilities with New Deal
- Understanding the Bank of Canada's Rate Decisions and Consensus
- Alvys Integrates Trimble’s PC*Miler for Enhanced User Experience
- Exploring Worksport's Innovative Launch of SOLIS and COR Systems
- Insider Trading Activity at New Horizon Aircraft Raises Eyebrows